← FDA ENFORCEMENT
Z-1984-2026Class II

Immuno-Mycologics, Inc

Recalling firm
Immuno-Mycologics, Inc
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Firm state
OK
Product quantity
101 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Neutralization Buffer may contain contaminants

Product description

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

Code / lot info

Lot: F5061154/UDI: 00816387021091

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.